Analysis system for analyzing biological samples

ABSTRACT

An analysis system for analyzing biological samples is disclosed, and which may comprise two or more analysis system components for performing an analysis. A sample workflow manager and an instrument manager coupled to the sample workflow manager may be coupled to the system components for receiving a process status from the system components, wherein the sample workflow manager provides at least one preconfigured processing route to the instrument manager in accordance with the process status. The instrument manager may comprise a memory for storing the preconfigured processing route, wherein the instrument manager is adapted for receiving a test order for analyzing the biological sample using the system components, and wherein the instrument manager is adapted for generating commands for controlling a transport device for transporting the biological sample in accordance with the test order and the at least one preconfigured processing route.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. § 119 ofEuropean Application No. 10 189 758.5, filed Nov. 3, 2010.

TECHNICAL FIELD

The disclosed embodiments relate to an analysis system for analyzingbiological samples, in particular an analysis system with a sampleworkflow manager.

BACKGROUND

In analytical laboratories, in particular clinical laboratories, amultitude of analyses on biological samples are executed in order todetermine physiological and biochemical states of patients beingindicative of a disease, nutrition habits, drug effectiveness or organfunction.

Biological samples used in those analyses can be a number of differentbiological fluids such as blood, urine, cerebral-spinal fluid, salivaetc. These original biological samples may further be aliquoted ordivided into multiple biological samples.

Modern clinical laboratories may use networks of analytical devices toautomatically analyze biological samples.

Disadvantages of the current automated systems for analyzing biologicalsamples include that there are real-time dependencies among analyticaldevices or subsystems of the laboratory automated system and that theremay be single point-of-failure dependencies.

SUMMARY

An analysis system for analyzing biological samples is disclosed. Theanalysis system may comprise at least first and second analysis systemcomponents for performing an analysis, wherein a first componentcomprises a transport device; and a second component comprises at leastone of a pre-analytic device, an analyzer and a post-analytic device forcharacterizing a property of a biological sample; and a sample workflowmanager and an instrument manager coupled to the sample workflowmanager, wherein the sample workflow manager is coupled to the at leastfirst and second analysis system components for receiving a processstatus from the at least first and second analysis system components,wherein the sample workflow manager provides at least one preconfiguredprocessing route to the instrument manager in accordance with theprocess status; wherein the instrument manager is coupled to thetransport device; wherein the instrument manager comprises a memory forstoring the at least one preconfigured processing route, wherein theinstrument manager is adapted for receiving a test order for analyzingthe biological sample using the second analysis system components,wherein the instrument manager is adapted for generating commands forcontrolling the transport device for transporting the biological sampleto the second analysis system component in accordance with the testorder and the at least one preconfigured processing route.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an analysis system according to one or moreembodiments shown and described herein;

FIG. 2 illustrates an analysis system according to one or moreembodiments shown and described herein;

FIG. 3 is a diagram which illustrates the workflow functions of a sampleworkflow manager according to one or more embodiments shown anddescribed herein;

FIG. 4 is a diagram which illustrates the functioning of an instrumentmanager according to one or more embodiments shown and described herein;

FIG. 5 illustrates an analysis system according to one or moreembodiments shown and described herein;

FIG. 6 illustrates an analysis system according to one or moreembodiments shown and described herein;

FIG. 7 illustrates an analysis system according to one or moreembodiments shown and described herein; and

FIG. 8 shows a flow chart which illustrates a method according to one ormore embodiments shown and described herein.

LIST OF REFERENCE NUMERALS

-   -   100 analysis system    -   102 sample workflow manager    -   104 instrument manager    -   106 second analytical device    -   108 third analytical device    -   110 fourth analytical device    -   112 first analytical device or conveyor line    -   114 biological sample    -   116 network    -   118 communication link between instrument manager and sample        workflow manager    -   120 communication link between instrument manager and first        analytical device    -   122 communication link between instrument manager and second        analytical device    -   124 communication link between instrument manager and third        analytical device    -   126 communication link between instrument manager and conveyor        line    -   128 processor    -   130 computer-readable storage medium    -   132 program    -   134 instructions    -   136 pre-analytic device    -   138 processor    -   140 computer-readable storage medium    -   142 program    -   144 instructions    -   146 analyzer    -   148 processor    -   150 computer-readable storage medium    -   152 program    -   154 instructions    -   156 post-analytic device    -   160 processor    -   162 computer-readable storage medium    -   164 program    -   166 test order    -   168 preconfigured process route    -   170 command generation module    -   172 sample tracking message    -   180 processor    -   182 computer-readable storage medium    -   184 program    -   186 process route database    -   188 process route creation module    -   189 process status    -   190 process route update module    -   192 rule set    -   193 updated process status    -   194 query    -   196 query response module    -   198 query response    -   200 analysis system    -   202 sample workflow manager    -   204 sets of possible workflows    -   206 rules for adjustment of workflow sets    -   208 sends current workflow set to instrument manager    -   210 instrument manager    -   212 current set of workflows    -   214 conveyor line    -   216 conveyor switching unit    -   218 sample 45    -   220 sample tracking message    -   222 instructions    -   224 route 1    -   226 route 2    -   228 analytical device    -   230 process status    -   500 analysis system    -   502 sample workflow manager    -   504 pre-configured processing route    -   506 instrument manager    -   508 control commands    -   510 pre-analytic apparatus    -   512 transport device    -   514 analyzer    -   516 test order    -   518 device status    -   520 set of pre analytic devices    -   522 set of analytical devices    -   600 laboratory information system    -   602 middle ware system    -   604 sample workflow manager    -   606 first scenario    -   608 pre-analytic apparatus    -   610 instrument manager    -   612 transport device    -   614 analyzer    -   616 instrument manager    -   618 instrument manager    -   700 analysis system    -   702 current process status    -   704 preconfigured processing routes    -   706 selection rules    -   708 route selection module    -   710 selected preconfigured processing route

DETAILED DESCRIPTION

Various embodiments of the present disclosure describe a systemarchitecture and communication structure allowing dynamic management ofthe sample across pre-analytics, analytics and post-analytic platformsor analytical devices. The management of the samples may allow fordynamic routing, aliquoting, sorting and buffering of samples dependingon the status of the analyzer, the available tests on the analyzer(status of test), the workload, and other relevant status informationfrom interacting systems.

The architecture shows an Instrument Manager (IM) in connection with thepre-analytical system as well as a Sample Workflow Manager (SWM). Inaccordance with the status information received from the connectedsystems the SWM may define valid routes the samples could take and thecriteria needed to decide what route to be assigned to a specific samplein accordance with processing orders, and container/specimencharacteristics.

Both the available routes as well as the criteria to select the routesare downloaded to the IM. The IM works with the actual configuration aslong as no updated information is received from the SWM.

In situations in which the SWM is not working, the IM will continueworking with the actual configuration. This may lead to a suboptimalmanagement of the samples but does not prevent the system fromprocessing the majority of the samples successfully.

Embodiments of the disclosure may include the avoidance of real-timedependences among subsystems of the Laboratory Automation System; theminimization of single-point-of-failure dependences wherein the DynamicWorkflow management may be viewed as an optimization, specifically,processing subsystems may be able to function without managementsubsystems. For example, with some default workflows; and decoupling ofthe subsystems which means development and testing of the subsystemsagainst interfaces and minimizing the need for testing of the entiresystem.

One embodiment described herein provides for an analysis system foranalyzing biological samples. Biological samples as used hereinencompass matter or material which contains matter that is originally ofbiological origin. The biological sample may be material entirely takenfrom an organism or it may be matter which is taken from an organism andprocessed by mixing with other material. For instance a blood or urinesample may be mixed with a preservative, a solvent or diluted. Thebiological sample also encompasses biological material which has beenbroken down or processed with chemicals such as enzymes or othermaterials for changing the chemical structure of the biological sample.

The analysis system comprises two or more analysis system components forperforming an analysis. An analysis system component as used hereinencompasses any device which is used for or contributes to theprocessing or analyzing a biological sample. An analysis systemcomponent is a component of an analysis system which is used for eitheranalyzing a biological sample or performs a contribution to the analysisof the biological sample. For instance, an analysis system component maybe an analyzer, a pre-analytical device, and a post-analytic device(such analysis system components may also be referred to by the termanalytical device). An analysis system component may be considered to bean element or component of an analysis system which contributes to thefunctioning of an analysis system, such as, the transport device orconveyor line.

An analytical device may be an analyzer for measuring a physicalproperty of the biological sample, such as a pre-analytical device, ananalyzer and a post-analytical device. An analytical device may also bea device for detecting the presence of certain biological materialswithin the biological sample. An analytical device further may be adevice which performs a transformation or action on a biological sample.For instance, an analytical device may perform pipetting or may addchemicals or otherwise process the biological sample.

At least one of the analysis system components may be an analyzer forcharacterizing a property of a biological sample. As mentionedpreviously, an analyzer as used herein is an analytical device whichperforms a measurement which may be used to characterize a property ofthe biological sample. The biological sample may be probed withelectromagnetic radiation or the biological sample may be exposed toother chemicals which cause a reaction if the biological sample hascertain properties or compositions.

At least one of the analysis system components may also be apre-analytic apparatus. As used herein, a pre-analytic apparatus is anapparatus which performs an operation on or a transformation of thebiological sample. For example, a pre-analytic device may open abiological sample, or perform a transformation such as adding a solventor material for diluting a biological sample. Examples of operationsperformed by pre-analytic devices include, but are not limited to:centrifugation, decapping, transportation, recapping, sorting, andaliquoting. During an operation performed by a pre-analytic apparatus,there may be a transformation of the biological sample. For example, areagent may be added to the biological sample. The transformation of thebiological sample by a pre-analytic apparatus may be for the preparationof a sample to facilitate or enable analysis of the sample by ananalyzer.

At least one of the analysis system components may be a transport devicefor transporting a biological sample between physical locations orbetween different analytical devices. A transport device may be, but isnot limited to, a conveyor system or a robotic arm. A transport devicecontributes to the analysis of a biological system by integratingdistinct analytical devices. In some examples a transport device may beintegrated with a pre-analytic apparatus or an analyzer.

The analysis system further comprises a sample workflow manager and aninstrument manager coupled to the sample workflow manager. An instrumentmanager may be a computer or a control system connected to two or moreanalysis system components and controls the function of the two or moreanalysis system components. In some embodiments at least one of theanalysis system components may be a transport device. In furtherembodiments, the instrument manager may control multiple analysis systemcomponents in addition to the transport device. The multiple analysissystem components may be any combination of pre-analytic devices,post-analytic devices and analyzers.

In yet a further embodiment, the instrument manager may control the twoor more analysis system components. In other embodiments, the instrumentmanager communicates with controllers which are embedded, onboard orotherwise integrated with the two or more analysis system components. Inthis embodiment, the instrument manager sends commands or communicateswith the two or more analysis system components.

A sample workflow manager encompasses a computer or a control systemwhich sends commands or instructions to the instrument manager. Thesample workflow manager determines preconfigured processing routes foruse by the instrument manager for controlling the two or more analysissystem components. For example, one of the analysis system componentsmay be a transport device. In some embodiments, the preconfiguredprocessing routes may be a set of commands which instruct the transportdevice to move a sample between a sequence of pre-analytic devices,post-analytic devices and analyzers.

The sample workflow manager is coupled to the two or more analysissystem components for receiving a process status from the two or moreanalysis system components. A process status may be data which isdescriptive of the current availability or status of each of the two ormore analysis system components. The process status can therefore beused for planning or controlling the workflow of the biological sampleas it is being analyzed by the analysis system. The sample workflowmanager provides at least one preconfigured processing route to theinstrument manager in accordance with the process status. A processingroute may be a set of commands or instructions that the instrumentmanager uses for completing workflow of a biological sample in theanalysis system.

In the analysis system, the planning of the workflow and the actualimplementation is divided into two separate components; the sampleworkflow manager and the instrument manager. The sample workflow managerplans the workflow on a higher level, and the instrument managerimplements or controls the two or more analysis system components toperform the analysis. For example, if one of the analysis systemcomponents is a transport device, the sample workflow manager may planthe workflow by specifying a set of targets which is descriptive of asequence of analysis system components. The instrument manager may thenimplement the workflow by controlling the transport device such that thebiological sample is transported according to the sequence of analysissystem components specified by the set of targets.

It is to be appreciated that if the sample workflow manager losesconnection with the analysis system components and/or the instrumentmanager then the analysis system will continue to process the biologicalsample. This is due to the workflow manager having the preconfiguredprocessing route once the processing of a biological sample begins. Inyet a further embodiment, the analysis system's workflow management andthe instrument management is divided wherein the instrument manager willnot become overloaded or over-flooded with data from the two or moreanalysis system components.

The sample workflow manager receives the process status from the two ormore analysis system components and generates or retrieves from adatabase at least one preconfigured processing route that is provided tothe instrument manager. Based on the preconfigured processing route, theinstrument manager controls the two or more analysis system componentsto process or analyze the biological sample. At least one of theanalysis system components may, for example, be a transport device. Theat least one preconfigured processing route may be a sequence ofanalysis system components to which the transport device transports thebiological sample.

The instrument manager is coupled to the at least two or more analysissystem components. The instrument manager comprises a memory for storingthe at least one preconfigured processing route. The instrument managermay be adapted for receiving a test order for analyzing the biologicalsample using the analyzer. The instrument manager may also be adaptedfor generating commands for controlling the transport of the biologicalsample to the analyzer in accordance with the test order and the atleast one preconfigured processing route.

In another embodiment, the sample workflow manager provides a singlepre-configured processing route for the biological sample. At least oneof the analysis system components may be a pre-analytical apparatus forperforming pre-analytic operations on the biological sample. In anotherembodiment, a transport device and the pre-analytic apparatus may beintegrated into a single unit. In yet a further embodiment, thepre-analytic apparatus is separate from the transport device and theanalyzer. The sample workflow manager may provide the singlepre-configured processing route before the pre-analytic apparatus hasfinished performing the pre-analytic operations on the biologicalsample.

In another embodiment, a transport device comprises at least oneconveyor line adapted for moving a sample holder containing thebiological sample between two or more analysis system components. Inthis embodiment, the transport device is an analysis system component.In another embodiment, the conveyor line is adapted for moving multiplesample holders each of which contain a biological sample between otheranalysis system components. The pre-configured processing routecomprises a set of targets. The set of targets is descriptive of asequence of the analysis system components. The set of targets specifythe order of the analysis system components to which a sample holder orthe biological sample within it is delivered to. In a furtherembodiment, the set of targets only specify the sequence of analysissystem components to which the biological sample is delivered to. Oncethe biological sample reaches an analysis system component, the analysissystem component may receive detailed instructions on how to process thebiological sample either from a laboratory information system or from amiddleware program which manages data from the laboratory informationsystem, or both.

The sequence of analysis system components may be chosen from theanalysis system components. The instrument manager provides the at leastone conveyor line with conveyance instructions for conveying thebiological sample to the sequence of analysis system components inaccordance with the set of targets.

In another embodiment, the pre-configured processing route comprises atleast one conditional statement. The at least one conditional statementprovides at least one alternative target to be substituted into the setof targets. The instrument manager may be adapted for receiving theprocess status. The instrument manager may also be adapted for modifyingthe conveyance instructions in accordance with the process status andthe at least one conditional statement. Therefore, if a particularanalysis system component is not functioning or is too busy theconditional statement can be used for further processing of thebiological sample without using the analysis system component that isnot available. Minimal processing time and monitoring of the biologicalsample is extremely minimal due to the conditional statement.

In another embodiment, the pre-analytic apparatus is an aliquotingdevice for aliquoting the biological sample. In the process ofaliquoting, the biological sample may be divided into equivalentbiological samples. For example, during the aliquotation process thebiological sample may be divided into multiple biological samples andeach of the derivative or child biological samples may have individualtargets which send the biological samples to a particular analyticaldevice.

The analysis system may be adapted for first processing the biologicalsample using the pre-analytic apparatus. The analysis system may furtherbe adapted for receiving the single pre-configured processing routebefore aliquoting the biological sample. The analysis system is furtheradapted for aliquoting the biological sample before conveying thebiological sample to the sequence of analysis system components.References to the biological sample in this context it is understoodthat biological sample may refer to the group of aliquoted biologicalsamples. Each of the derivative biological samples may also be routedseparately to different analysis system components.

In another embodiment, the two or more analysis system componentsreceive test orders for performing analysis from a laboratoryinformation system. In this embodiment, the biological sample or samplesare sent to the analytical devices using the set of targets. Once abiological sample reaches an analytical device, the analytical devicereceives the test order directly from the laboratory information system.

In another embodiment, the sample workflow manager may be adapted forrepeatedly receiving an updated process status from the two or moreanalysis system components. The updated process status encompasses datawhich is descriptive of the current process status of the two or moreanalysis system components. As the biological sample is being analyzedthe process status of various components of the analysis system maychange. For example, at least one of the analysis system components mayhave a malfunction or need service by an operator. Additional biologicalsamples may also be placed in the analysis system for analysis, in whichcase, in some instances it may be beneficial to change a preconfiguredprocessing route such that biological samples are processing moreefficiently. The updated processing status comprises data that would bedescriptive of such situations. The at least one preconfiguredprocessing route is updated repeatedly in accordance with the updatedprocessing status. The sample workflow manager is adapted for providingthe updated at least one preconfigured processing route to theinstrument manager. This embodiment allows the at least onepreconfigured processing route to be adjusted to use the analysis systemmore efficiently. In further embodiments, the sample workflow managermay select the updated at least one preconfigured processing route froma database. In yet further embodiments, a software module may be used tomodify the at least one preconfigured processing route.

In another embodiment, the sample workflow manager further comprises arule set containing rules for adjusting the at least one preconfiguredprocessing route in accordance with the updated process status. Thesample workflow manager is adapted for updating the at least onepreconfigured processing route in accordance with at least the rule setand the updated processing status. The rule set as used herein comprisesinstructions or computer code which may be used for adjusting the atleast one preconfigured processing route. For example, if an analysissystem component is non-functional there may be rules about which otheranalysis system component to route a biological sample to perform thesame function. There may also be rules which give certain biologicalsamples priority over other biological samples. There may also be ruleswhich control an optimization process for reducing the overall time foranalyzing all of the biological samples.

In another embodiment, at least one of the analysis system componentsmay be a pre-analytic apparatus for performing pre-analytic operationson the biological sample. The instrument manager may be adapted forgenerating commands for controlling the operation of the at least onepre-analytic apparatus in accordance with the at least one preconfiguredprocessing route.

In another embodiment, at least one of the analysis system componentsmay be a post-analytic apparatus for performing post-analytic operationson the biological sample. The instrument manager is adapted forgenerating commands for controlling the operation of the at least onepre-analytic apparatus in accordance with the at least one preconfiguredprocessing route. A post-analytic apparatus may be an apparatus whichdoes not perform a measurement on a biological sample but performs someoperation on the biological sample after a measurement has beenperformed. For example, a post-analytic apparatus may already cap abiological sample for storage. The post-analytic apparatus may alsoperform a transformation on a biological sample.

In another embodiment, the instrument manager may be adapted forreceiving sample tracking messages from the two or more analysis systemcomponents. Sample tracking messages encompass data which is descriptiveof the physical location and/or the processing status of a biologicalsample. For example, a sample tracking message may identify the locationof a biological sample as being within or being processed by ananalytical device. A tracking message may also be the identification ofa biological sample as being in transit or being transported between theanalysis system components. For example, the tracking message mayidentify the location of the biological sample on a conveyor orconveyance system. The instrument manager is able to update or changethe commands for controlling the transport of the biological samplebased on its status within an analysis system component or its physicallocation.

In another embodiment, the instrument manager may be adapted for sendinga query to the sample workflow manager. The query is a request forinstructions on how to process the biological sample using the two ormore analysis system components. The sample workflow manager may beadapted for constructing a query response in accordance with the query.The sample workflow manager may be adapted for sending the queryresponse to the instrument manager. The instrument manager may beadapted for providing commands to the two or more analysis systemcomponents in accordance with the query response. In some embodimentsthe instrument manager may send a query when there is some error orfailure which does not allow the preconfigured processing route to befollowed for a particular biological sample. A query may be also sent ifa predetermined set of conditions is met or exceeded, for example, if alarge number of biological samples is added for processing after theprocessing of the biological sample has been started. A query may alsobe triggered by a message from an analysis system component to theinstrument manager or by an analysis of data from an analysis systemcomponent by the instrument manager. For example, if some biologicalproperty of the biological sample is measured and is outside of anacceptable range, a query may be sent.

In a further embodiment, the analysis system may characterize multiplebiological samples. In another embodiment, the preconfigured processingroute may contain instructions for processing multiple biologicalsamples simultaneously.

In another embodiment, the analysis system further comprises at leastone conveyor line adapted for moving sample holders each containing oneof the multiple biological samples between the two or more analysissystem components. A conveyor line, as used herein, encompasses a systemfor conveying a biological sample between the two or more analysissystem components.

In another embodiment, the instrument manager may be adapted forcontrolling the movement of the sample holders using the conveyor lineusing commands generated in accordance with at least one preconfiguredprocessing route.

In another embodiment the sample workflow manager may provide multiplepreconfigured processing routes to the instrument manager in accordancewith the process status. The sample workflow manager may providepreconfigured processing routes for commonly or pre-specified types ofsamples. The sample workflow manager may also provide preconfiguredprocessing routes for previously used types of test orders. Theinstrument manager may be configured for selecting one of the multiplepreconfigured processing routes in accordance with the test order. Forexample, the instrument manager may select a preconfigured processingroute which routes the biological sample to a sequence of analysissystem components which are able to perform all the tests specified inthe test order.

The instrument manager may be further configured to use the one of themultiple preconfigured processing routes to generate the commands forcontrolling the transport device for transporting the biological sample.In this embodiment, the instrument manager may contain a number ofpreconfigured processing routes. The instrument manager itself may beable to select a preconfigured processing route which will satisfy thetest order. Therefore, the instrument manager is able to successfullyprocess the received test orders when the sample workflow manager is notfunctioning.

In another embodiment, the instrument manager may be configured forselecting the one of the multiple preconfigured processing routes suchthat all tasks requested by the test order are satisfied. In thisembodiment, the instrument manager may be able to independently selectthe preconfigured processing route used to generate the commands.

In another embodiment, the instrument manager may be configured forreceiving the process status. In some instances the process status thatthe instrument manager receives is an updated or current process status.For example, the process status may be different than the process statuswhen the sample workflow manager generated the multiple preconfiguredprocessing routes. The instrument manager may be configured to selectthe one of the multiple preconfigured processing routes by determiningwhich of the multiple preconfigured processing routes is allowed by theprocess status. In this embodiment, the status of the analysis systemmay be different when the sample workflow manager generated the multiplepreconfigured processing routes and when the instrument manager beginsto transport a biological sample. For instance, since the sampleworkflow manager generated the preconfigured processing routes aparticular analysis system component may malfunction. Using an updatedor current process status may enable the analysis system to functionbetter.

In another embodiment, the instrument manager may be configured toselect the one of the multiple preconfigured processing routes at leastpartially in accordance with a selection rule set. In this embodiment,predetermined rules can be used to select which of the multiplepreconfigured processing routes is used to transport the biologicalsample.

The rules used to select the preconfigured processing route may assign apriority to each rule. For instance more than one preconfiguredprocessing route may be allowed by the selection rule set. Assigning apriority to the selection rules enables the proper preconfiguredprocessing route to be selected. For example, routes “A” and “B” mayboth satisfy a first rule, “A” may satisfy a second rule, and “B” maysatisfy a third rule. If the second rule has a higher priority than thethird rule then route “A” is used.

The rules may select routes based on different levels of importance.Some rules may specify a particular order of analysis system componentto ensure that cross-contamination does not occur. Rules may alsospecify operations such that an aliquotation is performed.

Rules may also be used which sacred increase the efficiency or speed atwhich orders are produced. Rules may also specify analysis systemcomponents with a lower workload to be selected. Such rules could beused to reduce the number of analysis system components which are used.

Rules can also be used to increase the confidence of a measurement.Rules may sometimes specify that when a sample is rerun or retested thata particular test is done by the same analysis system component. In someinstances the rules may specify that when a sample is rerun or retestedthat a particular test is done by a different analysis system componentin order to compare the results.

Embodiments of the present disclosure are described in detail hereafterwith reference to the attached drawings.

FIG. 1 illustrates an analysis system 100 according to an embodiment ofthe present disclosure. Shown in FIG. 1 there is a sample workflowmanager 102, an instrument manager 104, a first analysis systemcomponent 112, a second analysis system component 106, a third analysissystem component 108, and a fourth 110. The first analysis systemcomponent is a conveyor line 112 for moving or conveying a biologicalsample 114 between the second, third, and fourth analysis systemcomponents 106, 108, 110. Shown in this embodiment there is a network116 which connects the computers or control devices of the sampleworkflow manager 102 and the second analysis system component 106, thethird analysis system component 108, and the fourth analysis systemcomponent 110. In some embodiments the conveyor line 112 is alsoconnected to the sample workflow manager 102 via the network 116. Thenetwork 116 is any computer network or communications system whichallows the second, third, and fourth analysis system component 106, 108,110 and the conveyor line 112 to send a process status to the sampleworkflow manager 102.

In addition there is a communication link 118 between the sampleworkflow manager and the instrument manager. The communication link isany suitable networking system or computer communication system whichallows two computers or control systems to exchange data andinformation.

There is also a communication link 120 between the instrument manager104 and the second analysis system component 106. There is acommunication link 122 between the instrument manager 104 and the thirdanalysis system component 108. There is another communication link 124between the instrument manager 104 and the fourth analysis systemcomponent 110. Also shown is a communication link 126 between theinstrument manager 104 and the conveyor line 112. These communicationlinks 118, 120, 122, 124, 126 allow the instrument manager 104 toexchange data and commands with any of these analysis system componentsthe instrument manager 104 is connected to. In some embodiments thenetwork 116 may be identical with the communication links 118, 120, 122,124, 126. There are however different ways of implementing this. In somealternative embodiments the conveyor line 112 and the second, third, andfourth analysis system components 106, 108, 110 are only connected tothe instrument manager 104 on a local network and all networkconnections from the conveyor line 112 and the second, third, and fourthanalysis system components 106, 108, 110 to the sample workflow manageris via the instrument manager 104.

The second analysis system component 106 comprises a pre-analytic device136. Essentially the second analysis system component 106 is apre-analytic apparatus. The second analysis system component 106 alsocomprises a processor 128 connected to the pre-analytic device 136 and acomputer-readable storage medium 130. The computer-readable storagemedium 130 contains a program 132 which the processor 128 uses tocontrol the operation and functioning of the pre-analytic device 136.The computer-readable storage medium 130 also contains instructions 134which the second analysis system component 106 receives from theinstrument manager 104. The instructions 134 are used by the program 132to control a pre-analytic operation on the biological sample 114 by thepre-analytic device 136.

The third analysis system component 108 comprises an analyzer 146. Theanalyzer 146 is for analyzing or measuring a physical property of thebiological sample 114. The analyzer 146 is connected to a processor 138which is connected to a computer-readable storage medium 140. Thecomputer-readable storage medium contains a program 142 and instructions144 received from the instrument manager 104. The processor 138 uses theprogram 142 for controlling the operation of the analyzer 146. Theinstructions 144 are used by the program 142 to generate specificcommands to the analyzer 146. The third analysis system component 108 isessentially an analyzer.

The fourth analysis system component 110 comprises a post-analyticdevice 156. The post-analytic device 156 is connected to a processor 148which is connected to a computer-readable storage medium 150. Thecomputer-readable storage medium 150 contains a program 152 andinstructions 154. The instructions 154 are received from the instrumentmanager 104. The processor 148 uses the program 152 in accordance withthe instructions 154 to control the functioning of the post-analyticdevice 156 on the biological sample 114.

The instrument manager 104 comprises a processor 160 and acomputer-readable storage medium 162. The computer-readable storagemedium 162 contains a program 164 which is used to control the operationof the instrument manager 104. The computer-readable storage medium 162also contains a test order 166 which the instrument manager 104 eitherreceived via a network connection, an email, input by an operator or wasautomatically generated when the biological sample 114 was placed intothe analysis system 100. The test order 166 is used by the program 164to initiate analysis of the biological sample 114 by the analysis system100. The computer-readable storage medium 162 also contains apreconfigured process route 168. The preconfigured process route 168 maybe received from the sample workflow manager 102. The computer-readablestorage medium 162 also contains a command generation module 170. Thecommand generation module 170 is computer executable code which uses thepreconfigured process route 168 to generate the instructions 134, 144,154 used by the analysis system components 106, 108, 110. Thecomputer-readable storage medium 162 also contains a sample trackingmessage 172 which may be received from one of the analysis systemcomponents 106, 108, 110, 112. The sample tracking message 172 containsdata which indicates the physical location and/or process status of thebiological sample 114.

The sample workflow manager 102 comprises a processor 180 and acomputer-readable storage medium 182. The computer-readable storagemedium 182 contains a program 184 for controlling the operation andfunction of the sample workflow manager 102. The computer-readablestorage medium 182 also contains a process route database 186. Theprocess route database 186 is an optional feature of the sample workflowmanager. The process route database 186 contains a database ofpreconfigured process routes. The computer-readable storage medium 182also contains a process route creation module 188. The process routecreation module 188 is an optional feature of the sample workflowmanager 102. The process route creation module 188 is used to generateat least one preconfigured process route 168. The computer-readablestorage medium 182 also contains a process status 189. The processstatus 189 may be used by the program 184 to either select apreconfigured process route from the process route database 186 and/oruse the process route creation module 188 to generate the preconfiguredprocess route 168. The computer-readable storage medium 182 alsocontains a process route update module 190. The process route updatemodule 190 is a rule set 192 to modify the preconfigured process route168 in accordance with an updated process status 193. Thecomputer-readable storage medium 182 also contains a query 194 receivedfrom the instrument manager 104 via the communication link 118. Thequery 194 contains data with a request for a decision on how to processthe biological sample 114. The computer-readable storage medium 182further contains a query response module 196 which generates a queryresponse 198 in accordance with the query 194. The sample workflowmanager 102 then sends the query response 198 to the instrument manager104. The command generation module 170 of the instrument manager 104 isable to use the query response 198 to generate instructions 134, 144,154 for operating the analysis system components 106, 108, 110 inaccordance with the query 194.

FIG. 2 shows a further embodiment of an analysis system 200 according toan embodiment of the present disclosure. The analysis system 200 in FIG.2 is illustrated functionally. There is a sample workflow manager 202.The sample workflow manager 202 contains sets of possible workflows 204.This may be considered equivalent to a database of possible workflows.The sample workflow manager 202 also contains rules for adjusting theworkflow set 206. The sample workflow manager 202 sends 208 the currentworkflows to the instrument manager 210. The instrument manager 210 isshown as containing a current set of workflows 212. In this instance theinstrument manager 210 is shown as being connected to a conveyor line214. The conveyor line 214 is a transport device. In this and in someembodiments the instrument manager may function as a pre-analyticaldevice. For example, samples may be loaded into the instrument manager.However, in other embodiments the instrument manager is separate fromthe analysis system components. The conveyor line 214 is connected to aconveyor switching unit 216. The conveyor switching unit 216 is able totransfer a sample 218 to different conveyor lines. The sample 218,number 45, is located in the conveyor switching unit 216. A decisionneeds to be made into which route, route number R1. 224 or route numberR2, 226, to switch sample 218, number 45. The conveyor switching unit216 sends a sample tracking message 220 to the instrument manager 210.In accordance with the current set of workflows 212 the instrumentmanager 210 sends a set of instructions 222 to the conveyor switchingunit 216. In this embodiment, the set of instructions 222 assigns sample218, number 45 to the second route 226. Also connected to route numberR1, 224 is an analysis system component 228. The analysis systemcomponent is able to send process status data 230 to the sample workflowmanager 202. The rules for adjusting the workflow set 206 adjust thesets of possible workflows 204 in accordance with the process statusdata 230.

FIG. 3 is a diagram which illustrates the workflow functions of thesample workflow manager according to a further embodiment of the presentdisclosure. The sample workflow manager 204 receives a variety of input.Arrow 300 represents the input of processing routes and rules possiblyby an operator or downloaded from an external system. Arrow 302represents the reception of a test order which includes thecharacteristics of specimens or biological samples which are covered orordered by the test order. Arrow 304 represents user interactions suchas manual test masking or manual control of the analysis system 100.Arrow 306 represents input received in the form of a process status fromthe analysis system components. Arrow 308 is another message receivedfrom the analysis system components which details the processingcapabilities of the analytical devices. Using these inputs the sampleworkflow manager provides several functions, first it managespreconfigured processing routes, it also decides on current active routeset based on the rules the current status and capabilities of thedevices. This is combined and workflow route sets are sent 310 to theinstrument manager 104. In addition the sample workflow manager 204 canrespond 312 to instrument manager queries with decisions for specificsample container or biological sample.

FIG. 4 is a diagram which illustrates the functioning of the instrumentmanager 210 according to a further embodiment of the present disclosure.The arrow 310 represents the receiving of workflow route sets from thesample workflow manager. The arrows 312 represent queries and receptionof a query response from the sample workflow manager. The arrow 400represents test orders including possibly specimen characteristics. Thearrow 402 represents interactions from users, for instance if there isan error or problem that needs to be determined or decided by anoperator. The arrow 404 represents sample tracking by the instrumentmanager. Using these inputs the instrument manager selects a route fromthe current active set based on the test orders and specimencharacteristics. Further, the instrument manager may also control theprocessing and transport of sample containers. The instrument manageralso at designated query points queries the sample workflow manager forroute decisions for specific sample containers and executing the sampleworkflow manager decisions. The arrow 406 represents the sending ofinstructions or commands for control of sample processing and transport.

FIG. 5 shows a further embodiment of an analysis system 500 according toa further embodiment of the present disclosure. In this embodiment thereis a sample workflow manager 502 which sends a pre-configured processingroute 504 to an instrument manager 506. The instrument manager 506receives a test order 516. The test order 516 may come from a laboratoryinformation system. The test order 516 may also be received via anetwork or the computer system, or from a user or operator. Theinstrument manager 506 sends a set of control commands 508 to atransport device 512. The transport device 512 is adapted for conveyinga biological sample between a pre-analytic apparatus 510 and an analyzer514. The pre-analytic apparatus 510, the transport device 512 and theanalyzer 514 are all adapted for sending device status 518, reports orinformation, to the sample workflow manager 502. The sample workflowmanager 502 may be adapted for using the device status 518 forgenerating the pre-configured processing route 504. Also marked on thediagram is the group 520 which is the set of pre-analytic devices. Inthis embodiment the transport device 512 is considered to be part of thepre-analytic devices. In other embodiments, the transport device may beseparate from the pre-analytic devices. Also marked on the diagram isthe group 522. This is the set of all analysis system components. Inthis group is the pre-analytic apparatus 510, the transport device 512,and the analyzer 514.

FIG. 6 shows a further embodiment of an analysis system according to afurther embodiment of the present disclosure. In this embodiment thereis a laboratory information system 600 which is connected to amiddleware system 602. A laboratory information system 600 as usedherein encompasses a system which is able to manage the operation andfunctioning of a laboratory for performing the analysis of biologicalsamples. The laboratory information system 600 may have a database ofsamples for which a test may be requested. A middleware system 602 asused herein encompasses a computer system or software program which isused to control multiple analytical systems together cooperatively. Inthis embodiment the sample workflow manager 604 is incorporated into themiddleware system 602. In some embodiments there may be multiple sampleworkflow managers 604 incorporated into the middleware system 602. Thelaboratory information system 600 is networked to the middleware system602. In some embodiments the laboratory information system 600 and themiddleware system 602 may be implemented on the same computer system. Inthis embodiment, the middleware system 602 is known as being networkedto a pre-analytic apparatus 608 and an analyzer 614. There is atransport device 612 for moving biological samples between thepre-analytic apparatus 608 and the analyzer 614. The pre-analyticapparatus 608 incorporates an instrument manager 610. Likewise theanalyzer 614 also incorporates an instrument manager 616. The brackets606 show and illustrate this first scenario wherein the pre-analyticapparatus 608 is shown as being connected or networked to the laboratoryinformation system 600. The analyzer 614 is also shown as beingnetworked or connected to the laboratory information system 600. In thisway the laboratory information system 600 may receive device status 518,reports or information. Likewise the sample workflow manager 604 mayalso receive device status 518, reports or information. In the firstscenario 606 the transport device 612 does not have an instrumentmanager. The brackets 618 show a second scenario which illustrates analternative embodiment. In this alternative embodiment the transportdevice 612 also incorporates an instrument manager 618. In thisembodiment the instrument manager 618 may also be able to send devicestatus 518, reports or information to the middleware system 602 and/orthe laboratory information system 600.

FIG. 7 illustrates an analysis system 700 according to a furtherembodiment of the present disclosure. The analysis system 700 shown issimilar to the analysis system shown in FIG. 1. The analysis system 700may be extended to any number of analysis system components. In theembodiment shown in FIG. 7, the instrument manager 104 has received acurrent process status 702. The current process status 702 may have beenreceived as messages from the different analysis system components 106,108, 110 or the instrument manager 104 may have polled the analysissystem components 106, 108, 110 for their current operational status.

The computer-readable storage medium 162 of the instrument manager 104is shown as containing multiple preconfigured processing routes 704. Thepreconfigured processing routes 704 were received from the sampleworkflow manager 102. The sample workflow manager 102 may for instanceprovide a number of preconfigured processing routes from its processroute database 186. The computer-readable storage medium 162 is furthershown as containing a set of selection rules 706 which may be used by aroute selection module 708. The route selection module 708 is computerexecutable code stored in the computer-readable storage medium whichuses the current process status 702 and/or the selection rules 706 toselect a selected preconfigured processing route 710.

FIG. 8 shows a flow diagram which illustrates a method which may beperformed using the analysis system 700 shown in FIG. 7. In a first step800, the sample workflow manager 102 receives a process status 189. Nextin step 802 the sample workflow manager 102 generates multiplepreconfigured processing routes 704. The multiple preconfiguredprocessing routes 704 may for instance be taken from the process routedatabase 186. Next in step 804 the instrument manager 104 receives themultiple preconfigured processing routes 704 from the sample workflowmanager 102.

Next in step 806, the instrument manager 104 receives a current processstatus 702. In some instances the current process status 702 may beidentical with the process status 189 or the updated process status 193.In other instances the current process status may indicate a differentoperational status for the analysis system components 106, 108, 110.Next in step 808, preconfigured processing routes 704 which cannot beperformed with the current process status 702 are eliminated fromconsideration. This prevents the sample workflow manager 102 fromchoosing a route which cannot be completed because a particular analysissystem component is overloaded or is currently not functioning. Next810, one of the multiple preconfigured processing routes 704 is selectedusing selection rules 706. Next in step 812, the instrument manager 104generates commands using the command generation module 170 and theselected preconfigured processing route 710. Finally in step 814 thebiological sample 114 is transported to a sequence of analysis systemcomponents using the commands that were just generated.

The method illustrated in FIG. 8 may be performed by a suitablyprogrammed computer or controller. A program or machine executableinstructions for performing the method may be stored on one or morenon-transitory computer readable storage mediums.

The present invention is not to be limited in scope by the specificembodiments described herein. Indeed, various modifications of thepresent invention, in addition to those described herein, will beapparent to those skilled in the art from the foregoing description andaccompanying drawings. Thus, such modification are intended to fallwithin the scope of the appended claims. Additionally, variousreferences are cited throughout the specification, the disclosures ofwhich are each incorporated herein by reference in their entirety.

What is claimed is:
 1. An analysis system for analyzing a biologicalsample comprising: an instrument manager; at least first and secondanalysis system components configured to perform an analysis, whereinthe first analysis system component comprises a transport device, andthe second analysis system component comprises at least one of apre-analytic device, an analyzer and a post-analytic device configuredto characterize a property of the biological sample, the second analysissystem component also comprises a pipetter configured to add chemicalsto the biological sample, and an embedded controller communicativelycoupled to the instrument manager; a sample workflow managercommunicatively coupled to the instrument manager, wherein the sampleworkflow manager is communicatively coupled to the at least first andsecond analysis system components and is configured to receive a processstatus from the at least first and second analysis system components,wherein the sample workflow manager is configured to provide at leastone preconfigured processing route to the instrument manager inaccordance with the process status; wherein the instrument manager iscommunicatively coupled to the transport device; wherein the instrumentmanager comprises a memory configured to store the at least onepreconfigured processing route received from the sample workflow managerand at least one additional preconfigured processing route, wherein theinstrument manager is configured to receive a test order and to analyzethe biological sample using the second analysis system component inaccordance to the test order, wherein the instrument manager isconfigured to generate commands to control the transport device which isarranged to physically transport the biological sample to the secondanalysis system component in accordance with the test order and the atleast one preconfigured processing route, and to switch to the at leastone additional preconfigured processing route when a failure is detectedby the instrument manager with regard to the at least one preconfiguredprocessing route when the test order is executed by the instrumentmanager; wherein the instrument manager is configured to determine,based on a selection rule set, when to retest the biological sample by adifferent analysis system component and to compare results; and whereinthe transport device is arranged to physically move a sample holdercontaining the biological sample into a switching unit, in which theswitching unit is arranged to change a direction of movement of thebiological sample along the transport device upon leaving the switchingunit, and in which the change in the direction of the movement of thebiological sample along the transport device upon leaving the switchingunit depends on the selection rule set and the component of the analysissystem to which the sample is moved by the transport device.
 2. Theanalysis system of claim 1, wherein the at least one additionalpreconfigured processing route is a plurality of additionalpreconfigured processing routes, and the instrument manager isconfigured to select a preconfigured processing route from among theplurality of additional preconfigured processing routes such that alltests requested by the test order are satisfied.
 3. The analysis systemof claim 1, wherein the instrument manager is configured to receive theprocess status from the at least first and second analysis systemcomponents, wherein the at least one additional preconfigured processingroute is a plurality of additional preconfigured processing routes, andthe instrument manager is configured to select a preconfiguredprocessing route from among the plurality of additional preconfiguredprocessing routes at least partially by determining which of theplurality of additional preconfigured processing routes is allowed bythe process status.
 4. The analysis system of claim 1, wherein the atleast one additional preconfigured processing route is a plurality ofadditional preconfigured processing routes, and the instrument manageris configured to select a preconfigured processing route from among theplurality of additional preconfigured processing routes at leastpartially in accordance with the selection rule set.
 5. The analysissystem of claim 1 further comprising a centrifuge configured tocentrifuge the biological sample.
 6. The analysis system of claim 1wherein the second analysis system component is configured to add anenzyme to the biological sample.
 7. The analysis system of claim 1wherein the workflow manager is configured to: detect that thebiological sample is measured to be outside of a range; and send a queryfrom the workflow manager upon.
 8. The analysis system of claim 1,wherein the post-analytic device is further configured to cap thebiological sample for storage.
 9. The analysis system of claim 1,wherein the instrument manager is configured to select an analysissystem component with a lower workload based upon the selection ruleset.
 10. A method for analyzing a biological sample comprising:providing an analysis system comprising: a sample workflow manager; aninstrument manager coupled communicatively to the sample workflowmanager; and at least first and second analysis system componentsperforming an analysis, wherein the first analysis system componentcomprises a transport device, and the second analysis system componentcomprises: at least one of a pre-analytic device, an analyzer and apost-analytic device that characterizes a property of the biologicalsample, a pipetter for adding chemicals to the biological sample, and anembedded controller communicating with the instrument manage, whereinthe sample workflow manager is communicatively coupled to the at leastfirst and second analysis system components and receives a processstatus from the at least first and second analysis system components,wherein the sample workflow manager provides at least one preconfiguredprocessing route to the instrument manager in accordance with theprocess status, wherein the instrument manager is communicativelycoupled to the transport device; wherein the instrument managercomprises a memory storing the at least one preconfigured processingroute received from the sample workflow manager and at least oneadditional preconfigured processing route, wherein the instrumentmanager receives a test order and analyzes the biological sample usingthe second analysis system component, wherein the instrument managergenerates commands to control the transport device, which physicallytransports the biological sample to the second analysis system componentin accordance with the test order and the at least one preconfiguredprocessing route, and to switch to the at least one additionalpreconfigured processing route when a failure is detected by theinstrument manager with regard to the at least one preconfiguredprocessing route when executing the test order, wherein the instrumentmanager determines, based on a selection rule set, when to retest thebiological sample by a different analysis system component and tocompare results, wherein the transport device physically moves a sampleholder containing the biological sample into a switching unit, whichchanges a direction of movement of the biological sample along thetransport device upon leaving the switching unit, the direction varyingdepending on the selection rule set and the component of the analysissystem to which the sample is moved; receiving by the sample workflowmanager the process status from the at least first and second analysissystem components; providing via the sample workflow manager the atleast one preconfigured processing route to the instrument manager inaccordance with the process status; controlling the transport device viathe instrument manager in accordance with the test order and the atleast one preconfigured processing route; moving, via the transportdevice, the sample holder containing the biological sample into theswitching unit; and changing the direction of movement of the biologicalsample along the transport device upon leaving the switching unit basedon the selection rule set and the component of the analysis system towhich the sample is being moved by the transport device.
 11. The methodof claim 10, wherein the at least one additional preconfiguredprocessing route is a plurality of additional preconfigured processingroutes, and the instrument manager selects a preconfigured processingroute from among the plurality of additional preconfigured processingroutes such that all tests requested by the test order are satisfied.12. The method of claim 10, wherein the at least one additionalpreconfigured processing route is a plurality of additionalpreconfigured processing routes, and the instrument manager selects apreconfigured processing route from among the plurality of additionalpreconfigured processing routes at least partially in accordance withthe selection rule set.
 13. The method of claim 10, further comprisingcentrifuging the biological sample.
 14. The method of claim 10 whereinthe second analysis system component adds an enzyme to the biologicalsample.
 15. The method of claim 10 further comprising: detecting thatthe biological sample is measured to be outside of a range; and sendinga query from the workflow manager upon.
 16. The method of claim 10further comprising capping the biological sample for storage.
 17. Themethod of claim 10 further comprising specifying selection of ananalysis system component with a lower workload based upon the selectionrule set.
 18. The method according to claim 10, further comprisingswitching to the at least one additional preconfigured processing routedue to a failure being detected by the instrument manager with regard tothe at least one preconfigured processing route.
 19. The methodaccording to claim 10, further comprising: determining, based on theselection rule set, a retest of the biological sample by a differentanalysis system component; and comparing results of the retest from thedifferent analysis component with the analysis performed by the secondanalysis system component.